Modification to Aeskulisa DS DNA G
FDA 510(k) K081251 · Aesku Diagnostics
510(k) numberK081251
Submission
- Device name
- Modification to Aeskulisa DS DNA G
- Applicant
- Aesku Diagnostics
Wendelsheim, Rheinland, DE - Received
- May 2, 2008
- Decision date
- May 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- LSW – Anti-Dna Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LSW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit…LSW · Traditional | Aesku.Diagnostics GmbH & Co. KG | 02/16/2018SE |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsLSW · Traditional | Inova Diagnostics, Inc. | 04/11/2016SE |
| K072393 | Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01LSW · Traditional | Phadia US, Inc. | 12/07/2007SE |
| K060380 | Fidis DsdnaLSW · Traditional | Biomedical Diagnostics (Bmd) SA | 05/02/2006SE |
| K041628 | Aeskulisa DS DNA GLSW · Traditional | Aesku Diagnostics | 10/14/2004SE |
| K921658 | Anti-Dsdna Antibody TestLSW · Traditional | Immco Diagnostics, Inc. | 03/22/1993SE |
| K872085 | The Gamma-B Anti-Ds DNA Kit & Optional ControlsLSW · Traditional | Immunodiagnostics, Ltd. | 09/01/1987SE |
More from Immunodiagnostics, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB · Traditional | 03/23/2018SE |
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit…LSW · Traditional | 02/16/2018SE |
| K132082 | Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-CheckMST · Traditional | 12/05/2013SE |
| K120889 | Aeskuslides Ana HEP-2DHN · Traditional | 10/15/2012SE |
| K091859 | Aesku PR3MOB · Traditional | 06/03/2010SE |
| K091860 | Aeskulisa Mpo, Model 30-7303USMOB · Traditional | 02/23/2010SE |
| K081104 | Aeskulisa Ana HEP-2, Ref 30-7115USLKJ · Traditional | 05/02/2008SE |
| K052439 | Aeskulisa Glia a and Aeskulisa Glia GMST · Traditional | 02/07/2006SE |
| K041628 | Aeskulisa DS DNA GLSW · Traditional | 10/14/2004SE |
| K041753 | Aeskulisa Ena 6 SLLL · Traditional | 07/14/2004SE |
Questions and answers
When was Modification to Aeskulisa DS DNA G cleared by the FDA?
Modification to Aeskulisa DS DNA G (K081251) received a 510(k) decision of Substantially Equivalent on May 13, 2008, 11 days after the submission was received.
What is the product code of K081251?
The FDA product code is LSW – Anti-Dna Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.